Are you an experienced regulatory affairs writer looking for a new challenge? We have just the opportunity for you! Our client, a top medical devices company, is seeking a Senior Regulatory Affairs Writer to join their dynamic team. This role offers a stimulating work environment at the forefront of medical research, along with ample opportunities for professional growth and development. And the best part? Itâs fully remote, allowing you to work from anywhere in Europe.
Responsibilities:
â Write and/or edit various clinical regulatory documents: As a Senior Regulatory Affairs Writer, you will be responsible for writing and editing a wide range of clinical regulatory documents, including CSRs, IBs, Protocols, Summaries, Briefing Books, Pediatric Plans, and Module 2 summaries for submissions. Your expertise in driving project consensus and foreseeing potential issues will be highly valued
â Oversee and mentor: Take on a leadership role and oversee outsourced writing deliverables. Provide guidance, support, and strategic assistance to the team. Youâll be responsible for ensuring that clinical documents are accurate, complete, and adhere to regulatory guidelines and company standards
â Collaborate and communicate: Be a clear communicator and a team player. Youâll work in a cross-functional environment, collaborating with various teams and stakeholders. Your ability to effectively communicate and drive project consensus will be key to your success in this role
Requirements:
â Life sciences background: A PhD/PharmD in life sciences (or related field) with a minimum of 5 years of experience, or a Masterâs degree in life sciences (or related field) with a minimum of 7 years of experience
â Willingness to learn and grow: Our client is looking for a motivated candidate who is eager to learn and grow as part of a team. While extensive experience is not required, a willingness to continuously develop your skills and contribute to the teamâs success is essential
â Problem-solving skills: As a Senior Regulatory Affairs Writer, youâll need to be a proactive problem solver. Your ability to anticipate issues, drive project consensus, and find solutions will be crucial in this role
â experience in Immunology, pneumology, and neuroscience (NS)
Benefits:
â Competitive compensation package: Our client understands the value of your skills and expertise. They offer a highly competitive compensation package that reflects your experience and contribution
â Professional growth and development: As a Senior Regulatory Affairs Writer, youâll have the opportunity to work on a diverse range of projects, from writing and editing clinical regulatory documents to providing oversight for outsourced deliverables. Youâll be able to enhance your skills and broaden your knowledge in the field of medical research
â Stimulating work environment: Join a team at the forefront of medical research, where every day brings new challenges and opportunities to make a difference. Collaborate with cross-functional teams and contribute to the development of crucial clinical regulatory documents that impact the advancement of medical science.
Apply now and become a part of this exciting journey!
Interested? Donât miss out on this exciting opportunity! Apply today and take your career to new heights. Send me a copy of your CV in Word format or share as this is a great opportunity for the right person! This is a 1 year contract and the client is looking for someone to start as soon as possible so please share your CV if interested, Forward to Oksana at [email protected] or via linked in. The rate can be either fixed FT or hourly.
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